Medical procedures such as balloon angioplasty and other catheterization procedures require the insertion of an instrument into a blood vessel through a conventional catheter introducer. When inserted within the blood vessel, the catheter and the catheter introducer are manipulated by the physician or other qualified medical personnel in a manner which can cause further enlargement of the incision. The specific size of the opening can vary depending upon the type of procedure and the size of the catheter used. But, regardless of the size of the catheter, some bleeding is usually associated with the removal of the device from the blood vessel. Bleeding from the wound can be more severe for some patients and the application of external pressure to the incision may not be sufficient to prevent a hematoma or an unsightly bruise.
Various devices and procedures have been proposed to resolve the above-discussed problem. In use, these devices are typically inserted into the incision or wound to dispense a clotting agent or a closure member. While it is generally preferred that at least the distal portion of the device extends into the blood vessel, the use of such prior art devices has resulted in at least a partial occlusion the vessel during the procedure. In some devices, the vessel remains at least partially occluded even after the device is withdrawn.
Several prior art devices dispense an expandable closure member or plug directly into the blood vessel. The closure member is affixed to a filament or suture which is used to secure the closure member against the inner surface of the blood vessel at the puncture sight to thereby seal the vessel and prevent further bleeding. Such closure members, however, are typically positioned within the vessel in a manner which results in the closure member not being contiguous with the inner lumen of the blood vessel and, consequently, the closure member can partially occlude the blood flowing through that area of the vessel. A potentially serious consequence of this is the deposition of plaque and thrombus formation. By way of example, the use of closure members or plugs is shown in U.S. Pat. Nos. 4,744,364; 4,890,612; and 5,061,274 to Kensey and U.S. Pat. No. 5,021,059 to Kensey et al.
Other devices dispense a clotting agent into the wound area. However, the clotting agent is typically dispensed as a viscous liquid which then must solidify. When in a liquid state, the clotting agent is capable of entering the blood vessel. Possible stenosis can result should the clotting agent solidify with a portion thereof protruding into the blood vessel. The use of clotting agents is exemplified in U.S. Pat. Nos. 5,129,882 and 5,221,259 to Weldon et al.
Other devices have attempted to prevent the intrusion of the clotting agent or plug into the blood vessel by providing a device adapted to partially extend into the blood vessel to form a surface contiguous with the inner lumen of the vessel around the incision. A vessel plug can be inserted into the wound the device prevents the overadvancement of the vessel plug into the blood vessel. One problem of such a device, however, has been that the portion of the device positioned within the vessel will at least partially occlude blood flow while the vessel plug is being positioned within the wound. Exemplary of such a device is that disclosed in U.S. Pat. No. 5,108,421 to Fowler.
The art has generally failed to provide an apparatus which effectively closes a puncture in the wall of the blood vessel and which also avoids occluding the vessel either by the device itself when in use or by the vessel plug or other material used to seal the wound. The present invention overcomes the aforementioned problems and shortcomings of the prior art by providing an apparatus and a method for inserting a vessel plug into a wound or incision wherein neither the apparatus nor the plug significantly interferes with the flow of blood through the vessel.
The apparatus of the present invention includes an expandable porous mesh mounted at the distal end of an elongate catheter or shaft. The apparatus is configured for insertion into a wound or incision through a sheath introducer to properly position the expandable mesh within the blood vessel or target organ. A control wire is connected to an inner surface of the expandable mesh and extends through the attached catheter where it is connected to a suitable actuating mechanism. The device is constructed so that a pulling force exerted on the control wire will cause the mesh to expand. The device can then be positioned in the wound with the expanded mesh against the inner surface of the blood vessel and contiguous with the wound or opening therein. A clotting agent or vessel plug is inserted in the wound and advanced along the shaft up to the expanded mesh. The mesh prevents the further advancement of the plug so that the distal end of the plug is substantially coextensive with the inner lumen of the vessel, thereby avoiding intrusion of the plug into the blood vessel. Once the plug is in place, the mesh can be relaxed again to assume a narrow profile and the apparatus can be removed while the plug remains in the incision to prevent additional bleeding and assist in coagulation.
The expandable mesh is manufactured with a porous network of fibers which allow blood to flow therethrough while the apparatus is positioned within the blood vessel. Additionally, the expandable mesh and the attached catheter may be treated with a non-thrombogenic substance to prevent significant clotting along the device and to permit free movement of the device within the plug after coagulation has started. Once the device is removed from the vessel, the plug will permit coagulation to take place at the puncture site while avoiding possible stenosis or thrombus formation which might result if the plug were to protrude into the vessel.
It is accordingly an object of the present invention to provide an improved apparatus and method for inserting a vessel plug into the body of a living patient.
It is another object of the present invention to provide the aforementioned improved apparatus to include an expandable porous mesh which can be inserted directly within a blood vessel without significantly interrupting blood flow through the vessel while the apparatus is in use.
It is still another object of the present invention to provide the aforementioned improved apparatus and method for its use wherein the expandable mesh can assume one orientation during insertion and withdrawal of the apparatus and another orientation when a vessel plug is being inserted within the wound or incision to thereby prevent the plug from entering the blood vessel.
These and other objects of the present invention will be more fully appreciated by those skilled in the art following a consideration of the remainder of the disclosure including the drawings, the detailed description of the preferred embodiment and the appended claims.